- Summit, Merck must navigate new regulatory terrain in China-first cancer landscapeSummit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be requir…BioSpace · 1d ago↗ source
- FDA has recommitted to adcomms—but to what end?The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings…BioSpace · 1d ago↗ source
- Recon: WHO releases first interim list of medical device authorities; AstraZeneca using AI to hedge late-stage risks<p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>